NOVO NORDISK INC FDA Approval NDA 022386

NDA 022386

NOVO NORDISK INC

FDA Drug Application

Application #022386

Documents

Letter2012-03-05
Letter2012-04-27
Label2008-06-26
Label2012-03-06
Letter2008-06-26
Letter2010-06-04
Label2010-06-03
Label2012-04-26
Review2009-04-14
Summary Review2009-04-14
Label2017-04-11
Letter2017-04-12
Label2017-12-11

Application Sponsors

NDA 022386NOVO NORDISK INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL500MG;1MG1PRANDIMETMETFORMIN HYDROCHLORIDE; REPAGLINIDE
002TABLET;ORAL500MG;2MG1PRANDIMETMETFORMIN HYDROCHLORIDE; REPAGLINIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2008-06-23STANDARD
LABELING; LabelingSUPPL2AP2010-05-28UNKNOWN
LABELING; LabelingSUPPL7AP2012-03-01STANDARD
LABELING; LabelingSUPPL8AP2012-04-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2013-10-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2013-10-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2014-06-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2014-07-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2014-06-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2014-06-04STANDARD
LABELING; LabelingSUPPL16AP2017-12-08STANDARD
LABELING; LabelingSUPPL18AP2017-04-05STANDARD

Submissions Property Types

ORIG1Null31
SUPPL2Null7
SUPPL7Null7
SUPPL8Null7
SUPPL9Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null15
SUPPL18Null15

CDER Filings

NOVO NORDISK INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22386
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRANDIMET","activeIngredients":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","strength":"500MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRANDIMET","activeIngredients":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","strength":"500MG;2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/08\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022386s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022386s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022386s000lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022386s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022386s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022386lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PRANDIMET","submission":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","actionType":"500MG;1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRANDIMET","submission":"METFORMIN HYDROCHLORIDE; REPAGLINIDE","actionType":"500MG;2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-08
        )

)

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